Efficacy and Safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women With High Stress and Anxiety: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
SF Research Institute, Inc.
Summary
This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women with High Stress and Anxiety. All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study. Subjects will be informed about the purpose of the study and signed informed consent will be taken. Subjects will be randomized to either one of the three treatment arms. Subjects will then be asked to either take one capsule containing the proprietary blend of Ashwagandha root extract or Ashwagandha root extract or Placebo orally twice daily with a glass of water for 8 weeks. The primary objective is to compare the efficacy of a proprietary blend of Ashwagandha root extract in adults experiencing stress and anxiety. The secondary objective is to compare the safety of a proprietary blend versus KSM-66 versus Placebo in adults experiencing stress and anxiety.
Description
To qualify for the study, participants must be aged between 18 to 55 years experiencing signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.). In this study, a maximum of 51 patients will be enrolled and the goal is to complete the study with at least 45 patients. After signing this consent form, participants will answer questions regarding their medical history, including any medications they are taking. Physical exams with vital signs (puls…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Adults (male and female) aged between 18 and 65 years. 2. Experiencing signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.). 3. Hamilton Anxiety Rating Scale (HAM-A) total score between 14 and 30 at the screening/randomization visit. 4. Perceived Stress Scale (PSS) score ≥13 at the screening/randomization visit. 5. BMI between 20 and 35. 6. No plan to commence new treatments over the study period. 7. Medication-free (an…
Interventions
- Dietary SupplementProprietary Blend of Ashwagandha
One capsule (300mg) is taken twice daily with water
- Dietary SupplementKSM-66 Ashwagandha root extract
One capsule (300mg) is taken twice daily with water
- Dietary SupplementPlacebo
One capsule (300mg) is taken twice daily with water
Location
- San Francisco Research InstituteSan Francisco, California